Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

Summary

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.

Timeline

Start

2020-04-27

Primary completion

2022-03-30

Completion

2022-11-28

Outcome

Met primary endpoint

paper The reduction in HbA1c was significantly greater with visepegenatide than placebo (LSM difference -0.73, 95% CI -0.96 to -0.50; p < 0.001). PMID 38948164 ↗

Publications

• Yan X, Ma J, Liu Y, Wang X, Li S, Yan S, Mo Z, Zhu Y, Lin J, Liu J, Jia Y, Liu L, Ding K, Xu M, Zhou Z. Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial. Lancet Reg Health West Pac. 2024 Jun 7;47:101101. doi: 10.1016/j.lanwpc.2024.101101. eCollection 2024 Jun.

Drugs

Indications